Certificate in Quality Management
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Course Overview
To provide the student with the necessary knowledge and understanding of the tools, processes and systems used to implementand maintain a compliant Quality Management System in a highly regulated and controlled manufacturing and/or service environment.
Understanding the Industry
Industry has highlighted through SECBA project engagement that there is a significant need for specialised expertise in many fields such as bioinformatics, analytical chemistry and biotechnology. Quality assurance and control are particularly crucial, with industry seeking competent analysts, Qualified Persons (QPs), and professionals skilled in Quality Management Systems (QMS) and ISO standards.
The growing reliance on technology, including computerized information management, automation and digital skills like bioinformatics and statistical analysis, further underscores the need for graduates with strong tech proficiency. Regulatory compliance, especially in Quality Control, validation, and adherence to standards, is also a priority. However, a noticeable talent gap exists, particularly for roles requiring specialised skills (e.g. cell culture). This highlights the importance of ongoing education and training in related fields to address the skills shortage and ensure a steady pipeline of qualified professionals for the sector.
Career Opportunities
Learners could gain employment within the sector (e.g. Wu-Xi Biologics, Pfizer, Almac, MSD, AbbVie, Grifols, Amryt Pharma etc.) and undertake the programme to obtain a recognised qualification.
Some learners may undertake the programme to ‘re-skill’ and move into the area, they are not employed, or perhaps employed in other Biopharmaceutical areas.
Course Delivery and Modules
This course will be delivered fully online over 1 semester.
Module Learning Outcomes
- Explain Quality Management and continuous improvement in Quality Systems.
- Evaluate how the concepts of Right First Time, Zero Defects, Quality by Design (QbD) and other preventative techniques can be used to continually improve quality.
- Explain a Kaizen Team based approach to Continuous Improvement (CI).
- Evaluate different Traceability formats, standards and design a basic Backward Traceability system.
- Explain how to design, document and assess (audit) a Quality Management System (QMS).
- Quality Management System (QMS)
The principles behind and differences between Quality Control (QC), Quality Assurance (QA) and Quality Management (QM). The philosophy behind Prevention e.g. Right First Time (RFT), Zero Defects (ZD) and Quality by Design (QbD) etc.
- Quality Tools
The methodologies developed and applied by Deming e.g. SPC, Introduction to Variation: types of variation (natural and special), sources of variation. The concepts of In/Out of Control and Capable/Not Capable processes.
- The Seven Quality Improvement Tools (7 QIT)
Introduction to the 7 QIT i.e. Flowcharts, checksheets, paretos, histograms, cause and effect (C&E) or fishbone diagrams, scatter plots and SPC.
- Teams
The philosophy and operational principles underpinning the Kaizen Team approach to Continuous Improvement.
- Basic Quality Management Systems
The basic Quality Management System (QMS) i.e. Quality Manual, Policy, Objectives, Standard Operating Procedures (SOP's), Records and Specifications. Documentation control and obsolescence.
- Traceability Systems
Batch definitions and traceability systems. Batch and Component traceability. Product recall process. How to design batch/traceability number.
- Auditing
Audit definitions. Types of audits i.e. Process Vs Checklist approach. Effective auditor characterists. Auditing methodologies. The corrective action (CA) and preventative action (PA)
Education Progression
Graduates of this course may progress to the Higher Certificate/ Diploma in Science in Biopharmaceutical Manufacturing or similar level 8 programmes.
Graduates of the Higher Diploma will be able to progress to level 9 taught postgraduate and Level 9 and 10 research programmes, including Level 9 and 10 research opportunities in DkIT.
Higher Diploma in Science in Biopharmaceutical Manufacturing
Certificate in Science in Biopharmaceutical Manufacturing New course
Fees and Funding
This programme is funded through the South East Cross Border Alliance (SECBA) project, supported by PEACEPLUS, a programme managed by the Special EU Programmes Body (SEUPB).
Fees
Entry requirements
Standard Entry Requirements
- Applicants for all the programmes should have a level 8 major award in Engineering / Science
or
- a Level 7 award in a cognate Science discipline (or equivalent)
or
- a Level 7 award in Engineering with a minimum of 2 years’ experience in the Pharmaceutical / Biopharmaceutical Industry. (or equivalent)
Applicants for whom English is not their first language must have English level of IELTS 6.0 or equivalent.
Non-Standard Entry Requirements
Any non-standard entries will be covered by Recognition of Prior Learning.
The part-time programmes are not available to international applicants (the programme includes delivery of practical content on campus, part-time programmes do not fulfil visa requirements).
Recognition of Prior Learning
Applicants who do not meet the standard academic entry requirements but have significant relevant experience (certified and/or experiential) may apply to access this programme via the Recognition of Prior Learning (RPL) route. Learn more about RPL at DkIT
How to apply
Applications will open soon. Register your interest below and we’ll notify you once they open.
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Disclaimer: All module titles are subject to change and for indicative purposes only. All courses are delivered subject to demand and timetables are subject to change. Elective Module options will only run subject to student numbers. The relevant Department will determine the viability of each elective module option proceeding depending on the number of students who choose that option. Students will be offered alternative elective modules on their programme should their preferred elective option not be proceeding. Award Options for Common Entry Programmes: The relevant Department will determine the viability of each award option proceeding depending on the number of students who choose either option. If the numbers for one of the Award options exceed available places, students for this option will be selected based on Academic Merit (highest grades).